Genetically modified organisms (GMOs)

Presentation and role of ANSES

Genetically modified organisms are defined as organisms or microorganisms that have undergone transformation of their genetic material through a process other than mating and/or natural recombination. They fall within the European Union regulatory framework and are evaluated by the European Food Safety Authority (EFSA). EFSA offers Member States the possibility of reviewing GMO dossiers to contribute to evaluation activities. ANSES provides support to the review process in this context.

Since the field of GMOs is strictly regulated and constantly changing, Member States have official laboratories that carry out surveillance and control activities including analyses, and scientific and technical monitoring. ANSES houses one of the three National Reference Laboratories (NRL) within its Plant Health Laboratory in Angers.

Background to GMOs

Genetically modified organisms (GMOs) are defined as organisms (plants or animals) or microorganisms in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination (As defined in Article 2 of European Directive 2001/18/EC).

Using genetic engineering techniques, it is possible to transfer certain genes from one organism to another, sometimes between different species. These methods can be used to introduce one or more genes carrying a new trait into the genetic make-up of another organism. The transferred genes can come from any type of organism since the genetic code is common to all organisms. This method can be applied to microorganisms, plants, and animals.

Assessment of GMOs

An EU regulatory framework has been set up for these organisms. All Marketing Authorisation (MA) applications submitted by industry, like applications dossiers for medicinal products, must be supported by scientific data characterising the product and proving that it complies with European regulatory requirements, the only applicable requirements in this field. Since 2003, the European Food Safety Authority (EFSA), which is responsible for this area, offers Member States the possibility of assessing dossiers. ANSES is involved in this review process and provides an opinion on the safety to health of the GMO and derived products, intended for human or animal food. On the basis of the Agency’s opinion, the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) communicates France’s comments on the dossiers to EFSA. EFSA then analyses the comments from all Member States and takes them into account when formulating its opinion.

The purpose of ANSES’s opinions

One of the missions of the Agency is to provide risk management ministries with independent, substantiated and up-to-date scientific analyses for each GMO that it evaluates. ANSES issues opinions on GMOs and their derivatives intended for use as food products for humans or animals.

The Agency is also responsible for rendering public the results of scientific assessments concerning the safety of foods. ANSES publishes this information in a completely independent and transparent manner.

The opinions of the Agency are also used to facilitate the government’s decision when the Member States vote on marketing authorisation for a GMO within the EU for use in food for human or animal consumption ( the Agency does not issue opinions on crops themselves).

ANSES: a key player in GMO assessment methods

Like the other national European agencies, and in collaboration with EFSA, ANSES assists in drafting and updating guidance documents intended for industry.

As soon as new substantiated scientific data are published in the literature, the Agency identifies and examines them in order to determine whether they have an impact on the Agency’s conclusions concerning the safety of consumption of a given GMO, provided these new data need to be taken into account for the continual revision of requirements imposed on industry. In 55% of cases, the Agency considers in its opinion that the data submitted by the company are not sufficient to arrive at a conclusion concerning the safety of consumption of the GMO.

Since 2002, the Agency has made a strong contribution to reinforcement of requirements concerning data and studies to be provided by industry, by identifying problem areas in the assessment of the health risks associated with consumption of GMOs. ANSES was the first organisation to reveal accidental contamination of conventional crops by GMOs, paving the way for a national and Europe-wide debate on this sensitive topic. The Agency was the first body in Europe to work on adaptation of the study protocol for subchronic toxicity by oral administration over 90 days of a part of the genetically modified plant. The Agency strongly recommends that this study be carried out for all new genetic transformations. In addition, the Agency carried out a thorough investigation concerning the statistical analysis of data from this study, aimed at increasing confidence in the interpretation of results.

Monitoring and control of GMOs: ANSES’s laboratory supporting the authorities

The Angers site of the Plant Health Laboratory was designated National Reference Laboratory (NRL) in the field of detection of GMOs for various plant species by the Ministerial Order of 19 October 2011. In this role, the laboratory has the following missions in support of the health authorities in its reference areas:

Official analysis of control plans within its remit, for example the control plan for maize crops;

Monitoring of transformation events being developed worldwide concerning the various plant species;

Evaluation or development of suitable analytical tools for the detection of GMOs whether authorised or not (from DNA extraction to identification of transformation events, when possible).

The Unit also participates actively in the French network of NRLs, with the BioGEVES laboratory and the Joint Laboratory Service Unit (SCL), in the European Network of GMO Laboratories (ENGL), in inter-laboratory tests for the validation of methods, and in AFNOR standardisation projects.